DOUBLE BOW TOOTH SEPARATOR
FDA 510(k) clearance K831136 · decided 1983-06-08
Clearance details
- K-number
- K831136
- Device name
- DOUBLE BOW TOOTH SEPARATOR
- Applicant
- Almore Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-07
- Decision date
- 1983-06-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JEP
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 (K091533) | Garrison Dental Solutions | 2009-08-17 |
| OMNI-MATRIX (K930151) | Innovative Technology , Ltd. | 1993-09-23 |
Recalls involving this device
No recalls on record reference this clearance.